Back to resultsPatient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) (PACE-AL)
Primary Purpose
Acute Leukemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise based multimodal intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Leukemia focused on measuring #14 Cancer Related fatigue, #13 Quality of Life, #12 "Psychosocial Intervention"[ti/ab], #11 Rehabilitation[tw], #10 "Physical Fitness"[tw], #9 "Physical Activity"[tw], #8 "Exercise Therapy"[tw], #7 Exercise[tw], #6 Hematologic[tw], #5 Hematological[tw], #4 Leukemia, Myeloid, Acute[mh], #3 "Acute Myeloid Leukemia"[tw], #2 "Acute Lymphoblastic Leukemia"[tw], #1 "Acute Leukemia"[tw]
Eligibility Criteria
Inclusion Criteria:
- Patients that are able to speak Danish > 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
- Normal EKG, blood pressure and pulse
- Signed informed written consent
Exclusion Criteria:
- Medical reason that contraindicates physical activity
- Patients diagnosed with a symptomatic cardial disease
- Documented bone metastasis
- Cognitively or emotionally unstable
- Unable to read or write in Danish
- Patients unable to carry out baseline tests
Sites / Locations
- Copenhagen University Hospital Rigshospital
- Herlev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise based multimodal intervention
Control Group
Arm Description
The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme
Control group receives usual care
Outcomes
Primary Outcome Measures
Six Minute Walk Distance 6MWD
Change in distance in meter
Secondary Outcome Measures
Estimated VO2 max Aastrand test
Change in l/m
Timed chair stand
Change in number of repetitions
Timed biceps curl
Change in number of repetitions
EORTC QLQ-C30
Change in scores for quality of life
FACT-An
Change in scores for quality of life/function
HADS
Change in scores for emotional wellbeing
SF36
Change in scores for general health
MDASI
Change in scores for symptom burden
Full Information
NCT ID
NCT01404520
First Posted
May 10, 2011
Last Updated
November 30, 2015
Sponsor
Universitetshospitalernes Center for Sygepleje
Collaborators
University of Copenhagen, Novo Nordisk A/S, Danish Cancer Society, Lundbeck Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01404520
Brief Title
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
Acronym
PACE-AL
Official Title
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitetshospitalernes Center for Sygepleje
Collaborators
University of Copenhagen, Novo Nordisk A/S, Danish Cancer Society, Lundbeck Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia
Keywords
#14 Cancer Related fatigue, #13 Quality of Life, #12 "Psychosocial Intervention"[ti/ab], #11 Rehabilitation[tw], #10 "Physical Fitness"[tw], #9 "Physical Activity"[tw], #8 "Exercise Therapy"[tw], #7 Exercise[tw], #6 Hematologic[tw], #5 Hematological[tw], #4 Leukemia, Myeloid, Acute[mh], #3 "Acute Myeloid Leukemia"[tw], #2 "Acute Lymphoblastic Leukemia"[tw], #1 "Acute Leukemia"[tw]
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise based multimodal intervention
Arm Type
Experimental
Arm Description
The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group receives usual care
Intervention Type
Other
Intervention Name(s)
Exercise based multimodal intervention
Intervention Description
The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.
Primary Outcome Measure Information:
Title
Six Minute Walk Distance 6MWD
Description
Change in distance in meter
Time Frame
Change from baseline in 6MWD at 12 weeks
Secondary Outcome Measure Information:
Title
Estimated VO2 max Aastrand test
Description
Change in l/m
Time Frame
Change from baseline in VO2 Aastrand test at 12 weeks
Title
Timed chair stand
Description
Change in number of repetitions
Time Frame
Change from baseline in timed chair stand at 12 weeks
Title
Timed biceps curl
Description
Change in number of repetitions
Time Frame
Change from baseline in timed bicep curl at 12 weeks
Title
EORTC QLQ-C30
Description
Change in scores for quality of life
Time Frame
Change from baseline in EORTC QLQ-C30 at 12 weeks
Title
FACT-An
Description
Change in scores for quality of life/function
Time Frame
Change from baseline in FACT-An at 12 weeks
Title
HADS
Description
Change in scores for emotional wellbeing
Time Frame
Change from baseline in HADS at 12 weeks
Title
SF36
Description
Change in scores for general health
Time Frame
Change from baseline in SF36 at 12 weeks
Title
MDASI
Description
Change in scores for symptom burden
Time Frame
Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients that are able to speak Danish > 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
Normal EKG, blood pressure and pulse
Signed informed written consent
Exclusion Criteria:
Medical reason that contraindicates physical activity
Patients diagnosed with a symptomatic cardial disease
Documented bone metastasis
Cognitively or emotionally unstable
Unable to read or write in Danish
Patients unable to carry out baseline tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jarden, Ph.D.
Organizational Affiliation
UCSF and CIRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Rigshospital
City
Copenhagen
ZIP/Postal Code
DK 2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
DK 2730
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27036163
Citation
Jarden M, Moller T, Christensen KB, Kjeldsen L, Birgens HS, Adamsen L. Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial 'PACE-AL'. Haematologica. 2016 Jul;101(7):e316-9. doi: 10.3324/haematol.2015.140152. Epub 2016 Apr 1. No abstract available.
Results Reference
derived
PubMed Identifier
24083543
Citation
Jarden M, Moller T, Kjeldsen L, Birgens H, Christensen JF, Bang Christensen K, Diderichsen F, Hendriksen C, Adamsen L. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial. BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446.
Results Reference
derived
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Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
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